Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL

NCT04168788 | Unknown

• 1 other identifier: 49RC19_0197
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

Brief Summary

Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children. The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

Conditions

Hepatic Veno-Occlusive Disease; Nephroblastoma; Acute Lymphoblastic Leukemia

Keywords

Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Correlate pharmacogenetic analysis with veno-occlusive disease.

  Illumina's "Human Omni2.5-8 v1.3" microarrays explore more than 2,600,000 genetic variants, thus covering the entire genome with more than 300,000 genetic biomarkers in exons.

  One day

Secondary Outcomes (1)

• Participant characteristics.

  One day

Study Arms (1)

Nephrobalstoma or ALL

OTHER

Pateints treated for a nephrobalstoma or ALL in childhood or adolescence

Other: Blood test for genetic analysis

Interventions

Blood test for genetic analysis OTHER

Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Nephrobalstoma or ALL

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged \< 18 years old at the time of cancer diagnosis
• Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation
• Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
• Affiliated to a Social Security scheme

You may not qualify if:

• Unavaibility of constitutional DNA
• Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence
• Pregnant, lactating or parturient women
• Person deprived of their liberty by judicial or administrative decision
• Person under psychiatric care under duress
• Person subject to legal protection
• Person unable to express their consent

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (16)

Univesity Hostipal of Amiens

Amiens, 80054, France

Location

University Hospital of Bordeaux

Bordeaux, 33000, France

Location

University of Brest

Brest, 29609, France

Location

University Hospital of Dijon

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

University Hospital of Limoges

Limoges, 87042, France

Location

Hôpital La Timone

Marseille, 13385, France

Location

University Hospital of Nantes

Nantes, 44093, France

Location

University Hospital of Nice

Nice, 06200, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Trousseau

Paris, 75571, France

Location

University Hospital of Poitiers

Poitiers, 86000, France

Location

University Hospital of Rennes

Rennes, 35203, France

Location

University Hospital of La Réunion

Saint-Denis, 97400, France

Location

University Hospital of Tours

Tours, 37044, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease; Wilms Tumor; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Hematologic Tests; Genetic Testing

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Isabelle Pellier, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Jolivot, MD

CONTACT

33-(0)2-41-35-58-08; DeJolivot@chu-angers.fr

Sybille Lazareff, CRA

CONTACT

33-(0)2-41-35-33-42; SyLazareff@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 19, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)